NCT00206947

The CAMPUS Project: Cholinergic Augmentation of Cognitive Deficits in Schizophrenia

PHARMACOLOGICAL TREATMENT OF COGNITIVE DEFICITS IN SCHIZOPHRENIC PATIENTS: The Effects of Central Cholinergic Augmentation on Cognitive Deficits and Psychopathology

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Birte Glenthoj · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The present study will specify and delineate the separate components of cognitive deficits and examine the effects of adjunctive cholinergic augmentation on these cognitive deficits as well as psychopathology in schizophrenic patients treated with an antipsychotic compound with no aberrant binding affinity for the cholinergic receptor system. The hypothesis is that cholinergic augmentation using donepezil will improve cognitive deficits, sensory gating deficits, and psychopathology in schizophrenic patients treated with an atypical antipsychotic (ziprasidone).

Detailed description

The purpose of the study was to examine the effects of cholinergic augmentation of atypical antipsychotic medication on: * Cognitive deficits * Sensorimotor gating * Psychopathology The primary objective was to examine: • The effects of donepezil, compared to the effects of placebo, on cognitive function, sensorimotor gating and psychopathology in patients treated with an atypical antipsychotic (ziprasidone). Secondary objectives are to examine: * The effect of donepezil, compared to the effects of placebo, on cognitive function, sensorimotor gating and psychopathology in patients treated with ziprasidone. * Which specific areas of cognitive deficits benefit from cholinergic augmentation of atypical antipsychotic treatment. * The interactions between cognitive deficits and psychopathology: To what extent the effects of cholinergic augmentation on psychopathology, sensorimotor gating, and cognition are independent or correlated. * Which specific brain areas are activated during cholinergic augmentation of treatment with an atypical antipsychotic drug (ziprasidone). Participants: Schizophrenic men and women between the ages 18 to 55 who meet the ICD-10 criteria for schizophrenia living in the catchment area of the psychiatric departments of Bispebjerg University Hospital,Rigshospitalet, or Psychiatric Center, Glostrup. Patients can be either unmedicated, or need to be switched from other antipsychotic medications due to side-effects, or lack of effect on negative symptoms, positive symptoms, or cognitive function. Patients can be enrolled in the study as inpatients or outpatients, and changes in hospitalization status during the trial are allowed. Patients were stabilized on antipsychotic medication (ziprasidone) before they were randomized to treatment with either donepezil or placebo.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	donepezil (5-10 mg/day)	Donepezil will be administered in a dose optimized for treatment, to patients who are stabilized on a ziprasidone treatment
DRUG	Placebo	Placebo will be added to the medication of schizophrenia patients who are first stabilized on a ziprasidone treatment

Timeline

• Start date: 2002-12-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2005-09-21
• Last updated: 2011-09-20

Locations

4 sites across 1 country: Denmark